Prostatic HyperplasiaPhase 3NCT00169585
Levofloxacin For The Management Of Patients With Abnormal Prostate Specific Antigen (PSA)
A Phase 3 study testing Levofloxacin oral tablets in people with Prostatic Hyperplasia and Prostatitis, run by GlaxoSmithKline at 19 sites in Italy.
Trial summary
Multicentric, national, prospective, parallel group, controlled. The Subjects in every center will be randomized and assigned to the pharmacologic arm or the one with the biochemical monitoring Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia, Prostatitis
- What is being tested?
- Levofloxacin oral tablets
- Type of treatment
- Pill or oral medicine
- How many people
- 240 participants
- Where
- 19 sitesItaly
- Study dates
- Mar 2005to Apr 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Only subjects who meet all of the following criteria will be eligible to participate in this study:
- Male patients
- Age ≥ 45 years
- Suspected presence of prostate inflammatory foci, defined according to the following criteria:
- PSA ≥ 2.6 ng/mL and age ≥ 50 and < 60 years (or ≥ 45 years if the patient has known family predisposition to carcinoma of the prostate) or,
- PSA ≥ 4.1 ng/mL and age ≥ 60 and < 75 years, and
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- normal digito-rectal examination (DRE) (see section 5.2), and normal urine test with dipstick and/or microscopy carried out within 5 days of the baseline visit
- Patients willing and able to provide their written informed consent and to comply with study procedures.
- Patients with LUTS/BPH on watchful waiting or already under treatment with alpha-blockers or 5-ARI (5-alpha reductase inhibitors) for at least 6 months will also be considered eligible to participate in the study.
Who cannot join
- Patients who meet any of the following criteria will not be eligible to participate in this study:
- Diagnosis of NIH class I-III prostatitis or clinical evidence of active acute urinary infection and/or known or suspected active bacterial infection at other sites;
- Diagnosis of prostate carcinoma (or PIN or ASAPS) or prior radical prostatectomy or radiotherapy or other treatments for prostate cancer;
- PSA > 20 ng/mL;
- PSA values (including high values) stable over time;
- Start of a pharmacological therapy with 5-ARI in subjects with LUTS/BPH;
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- Permanent catheter;
- Prior treatment (within 4 weeks) with levofloxacin for genital-urinary infections;
- Known or suspected allergy to levofloxacin, including the excipients contained in the pharmacological preparation and/or confirmed tendency to photosensitivity reactions after fluoroquinolone therapy;
- Concomitant treatment with drugs not allowed in the study
- Reluctance to undergo prostate biopsy and/or risk of non-compliance;
- History or current evidence of alcohol or drug abuse in the last 12 months;
- History of any conditions that, in the opinion of the investigator, may confound the study results or create additional risks for the patient.
- Participation in any study of investigational or marketed drugs within 30 days before the baseline visit or during the study.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
Italy19 sites
GSK Investigational Site
Avellino, Campania, 83100
GSK Investigational Site
Bagno A Ripoli (FI), Tuscany, 50126
GSK Investigational Site
Bari, Apulia, 70124
GSK Investigational Site
Bologna, Emilia-Romagna, 40138
GSK Investigational Site
Catania, Sicily, 95124
GSK Investigational Site
Foggia, Apulia, 71100
GSK Investigational Site
Lanzo Torinese (TO), Piedmont, 10074
GSK Investigational Site
Lecco, Lombardy, 23100
GSK Investigational Site
Matera, Basilicate, 75100
GSK Investigational Site
Messina, Sicily, 98125
GSK Investigational Site
Milan, Lombardy, 20123
GSK Investigational Site
Milan, Lombardy, 20132
GSK Investigational Site
Milan, Lombardy, 20142
GSK Investigational Site
Naples, Campania, 80131
GSK Investigational Site
Orbassano (TO), Piedmont, 10043
GSK Investigational Site
Rome, Lazio, 00168
GSK Investigational Site
Rome, Lazio, 00189
GSK Investigational Site
Sassari, Sardinia, 07100
GSK Investigational Site
Turin, Piedmont, 10126
About this study
Official title: A National, Multicentric, Randomised, Controlled Trial. Applications of a Critical Pathway Using Levofloxacin for the Management of Patients With Abnormal PSA.
Multicentric, national, prospective, parallel group, controlled. The Subjects in every center will be randomized and assigned to the pharmacologic arm or the one with the biochemical monitoring
- Conditions
- Prostatic Hyperplasia, Prostatitis
- Being tested
- Levofloxacin oral tablets
- Keywords
- diagnostic-therapeutic pathway, PSA, DRE, Levofloxacin
- Medical subject headings
- Prostatic Hyperplasia, Prostatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Levofloxacin oral tabletsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate if the application of 3 weeks treatment of levofloxacin, compared with the execution of a prostatic biopsy, after biochemical monitoring of total PSA, could decrease significantly the level of serum concentration of total PSA in 6-7 weeks.
Measured: 6/7 week after treatment
Secondary outcomes (1)
Normalization of serum concentration of total PSA; Changes in the time of levels of total PSA concentrations; Impact on patients''Qol(Quality of Life); Costs associated to both choices.
Measured: 24 weeks (follow-up visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, MD, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169585
- Sponsor's protocol ID
- LEV102341
- Status last verified
- May 2017
- First submitted
- 12 Sep 2005
- Last updated
- 30 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National, Multicentric, Randomised, Controlled Trial. Applications of a Critical Pathway Using Levofloxacin for the Management of Patients With Abnormal PSA.
- ClinicalTrials.gov ID
- NCT00169585
- Acronym / sponsor ID
- LEV102341
- Conditions
- Prostatic Hyperplasia, Prostatitis
- Keywords
- diagnostic-therapeutic pathway, PSA, DRE, Levofloxacin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Mar 2005
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Multicentric, national, prospective, parallel group, controlled. The Subjects in every center will be randomized and assigned to the pharmacologic arm or the one with the biochemical monitoring
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Only subjects who meet all of the following criteria will be eligible to participate in this study:
- Male patients
- Age ≥ 45 years
- Suspected presence of prostate inflammatory foci, defined according to the following criteria:
- PSA ≥ 2.6 ng/mL and age ≥ 50 and < 60 years (or ≥ 45 years if the patient has known family predisposition to carcinoma of the prostate) or,
Key exclusion criteria (14 listed)
- Patients who meet any of the following criteria will not be eligible to participate in this study:
- Diagnosis of NIH class I-III prostatitis or clinical evidence of active acute urinary infection and/or known or suspected active bacterial infection at other sites;
- Diagnosis of prostate carcinoma (or PIN or ASAPS) or prior radical prostatectomy or radiotherapy or other treatments for prostate cancer;
- PSA > 20 ng/mL;
- PSA values (including high values) stable over time;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Levofloxacin oral tablets | Drug | – |
Primary outcome
To evaluate if the application of 3 weeks treatment of levofloxacin, compared with the execution of a prostatic biopsy, after biochemical monitoring of total PSA, could decrease significantly the level of serum concentration of total PSA in 6-7 weeks.
Time frame: 6/7 week after treatment
1 secondary outcome
Normalization of serum concentration of total PSA; Changes in the time of levels of total PSA concentrations; Impact on patients''Qol(Quality of Life); Costs associated to both choices.
Time frame: 24 weeks (follow-up visit)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials, MD study director
GlaxoSmithKline
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Levofloxacin oral tablets in people with Prostatic Hyperplasia and Prostatitis, run by GlaxoSmithKline at 19 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate if the application of 3 weeks treatment of levofloxacin, compared with the execution of a prostatic biopsy, after biochemical monitoring of total PSA, could decrease significantly the level of serum concentration of total PSA in 6-7 weeks. (time frame: 6/7 week after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2017.